A Rapid Way— on Short Notice— to Keep America Functioning Normally on a Day-to-Day Basis During the Next Covid or Respiratory Virus Pandemic: It’s Through the Nose and Implementing the Lessons Learned of Nasal Spray Steroids on Allergic Rhinitis and Sinusitis

Stephen L. DeFelice, M.D.

Chairman, FIM

The Foundation for Innovation in Medicine


The Nasal Spray Rationale

During a Covid or respiratory virus pandemic the primary medical
objective is to eliminate or control the disease with effective vaccines
and pharmaceuticals and substantially diminish the devastating mental,
physical and economic damages.
But there is another critical yet little-mentioned national objective that
recently dawned on me. It’s a way to counteract or control such
damage until effective vaccines and pharmaceuticals are available to do
their job or the pandemic naturally dissipates. And the good news is
that such a possibility does exist and which it, unlike vaccines and
drugs, can be rapidly developed and distributed. It’s by the use of nasal
sprays which prevent viruses from attaching to the nasal mucosa and
entering the body or by any other mechanism. So with a few squirts in
the morning and maybe at night, a teacher can safely go to class,
doctors and nurses to their hospitals and many millions to their jobs. As
a result, our country’s devastating social-economic impact would be
substantially reduced.
This post deals with how I stumbled upon this hopefully doable
opportunity and the need to somehow establish a national nasal spray
approach— rapidly.

A Call for a National Approach

The Covid pandemic had effectively destabilized our nation bringing it
perilously close to its knees. Though we may be on the mend, there is
little doubt that a future Covid pandemic where effective vaccines or
drugs will not be available may be on its way leaving us only with masks
and distancing to protect us. Many knowledgeable physicians and
scientists would not be surprised that such a new Covid mutant or
variant will indeed abruptly appear and mightily strike us leaving us
So where do we look for a type of therapy that will keep our country
functioning during future pandemics? It’s in the Nose and
understanding the broad cultural impact of nasal spray steroids on
allergic rhinitis and sinusitis.
During the dreaded allergy season, millions of Americans experience
the debilitating signs and symptoms of allergic rhinitis and sinusitis.
Such suffering includes a relentless runny nose, pressure headaches,
insomnia, fatigue, feeling miserable and diminished mental acuity all of
which lead to a substantial reduction of our national work productivity
such as in the family, schools, government, business, military and
religion, as well as other sectors. And also let’s not forget that, despite
years of intensive research efforts, there are no general drugs, vaccines
or any other type of cures available during the allergy seasons. So
another medical approach was needed to keep our country functioning
as normally as possible on a day-to-day basis during these seasons. The
steroid nasal spray is such a therapy. It’s highly effective in reducing the
debilitating allergic clinical manifestations making it possible for men,
women and children to function more normally. So it makes compelling
sense to take a similar medical approach to Covid and other respiratory viruses. And for some inexplicable reason we currently lack such a
sensible and unquestionably uncomplicated doable approach in the
face of potential oncoming Covid and other respiratory viruses.
You may be wondering how I came upon this approach. An old
colleague and well-respected scientist contacted me asking my advice
regarding his discovery of a nasal spray that was shown in multiple
laboratory studies to block the entry of the Covid virus through the
nasal mucosa or cells preventing it from entering at the point of entry
to the body.
To my surprise, there are indeed a number of such highly promising
laboratory studies, including those conducted by a division of the
National Institutes of Health, which confirm this effect.
Now I’m going to stick my head out on a limb because the critical need
for such a national weapon against respiratory viruses mandates taking
risks, even personal ones. For the record, I’ve had an extensive career
in evaluating laboratory studies which are necessary to help me design
clinical studies, place and oversee the actual studies and, after
completion, evaluate their results. I instituted the Peer Group concept
selecting a group of creative, independent physicians and scientists to
help guide every step of the process. I managed a substantial number
of clinical studies in the capacity of medical director of pharmaceutical
company divisions, chief of certain clinical studies for the Department
of Defense during the Vietnam War and establishing the first CRO or
private Clinical Research Organization which plans and manages clinical
studies for domestic and international pharmaceutical companies.
Based on such broad personal experience, I believe that it is reasonable
to be optimistic that this nasal spray has a good chance to be clinically
effective as a prevention weapon.

Drugs or pharmaceuticals such as aspirin or anti-Covid ones must in
clinical studies undergo multiple biological steps such as intestinal
absorption, proper distribution to the site where it’s supposed to be
effective and then metabolized in order to be eliminated from the
body. In addition, they must be shown to be acceptably safe. Because
of this highly complicated, multi-step path, most promising drugs
discovered in laboratory research fail to be proven to be both clinically
effective and/or safe.
But this nasal spray, like certain others, does not go through these
multiple steps for it, by just a single act, simply kills or immobilizes
bacteria, viruses and fungi by acting on their surfaces like the
disinfectant chlorine on a kitchen counter and antiseptic alcohol in hand
sanitizers making its predictability of activity on any surface such as
human nasal mucosa cells extremely high.
And, before I forget, the ingredients of my colleague’s nasal spray are
extremely safe. So I said to myself, that because of the aforementioned
facts and taking into account the urgency of maintaining national
security, promising treatments such as this should be immediately and
aggressively pursued with creatively designed clinical studies backed by
sufficient financial support. If you’re going to do something this
important, do it right!

The Small Nasal Spray Clinical Study

The intended objective of the nasal spray clinical study was to prevent
the attachment of the Covid virus to the nasal mucosa and not to treat
an already infected nasal cavity such as is done with oral
pharmaceuticals. But the cost of conducting a prevention study is
prohibitively high. The pharmaceutical industry evaluated tens of thousands of volunteers spending multi- millions of dollars in order to
demonstrate the preventative effects of their vaccines.
The sponsor of this study did not have such deep pockets and,
therefore, supported a very small yet well-designed study in patients
who were already infected with Covid as determined by presence of
the virus in the nasal cavity. In other words, it was a treatment study.
The study results were not statistically significant, but I thought that if
the number of volunteers were much larger, there may have been a
highly significant clinical effect on the most important
measurement—the disappearance of the virus from the nasal cavity. If
so, it may signal a significant breakthrough. Maybe this statistical
exercise should still be done.

What Would You Do if You Were in My shoes? Here’s What I’m Going to Try

Here’s how I view the situation and decided what to try to do: Though
the results of the laboratory studies including animals are highly
promising, significant support and enthusiasm from academic sectors is
lacking which presents a credibility problem. But I have no reason not
to accept their results, particularly since the NIH participated in such
studies. And, based on my experience, I believe that there’s a high
probability that the nasal spray will be clinically effective in preventing
Covid viruses from passing through the nasal mucosa. Yet, to my
knowledge, no preventive clinical study is planned and a golden
opportunity will be lost to our country.
Now with the current surge of B.4, B.5 and God knows what other
mutants are on the way —soon!— I must make the assumption that our vaccines and drugs may not be sufficiently effective when they
So I’m thinking where does that leave us? It’s in an already vulnerable
country where our day-to-day operations will immediately be crippled
and the inevitable destructive consequences will be enormous. And I
concluded that an energetic national nasal spray approach is a
compelling logical and short- term solution, and I’ll try to spread the
word by my foundation in an attempt to find influential others who can
move the ball. At age 86, I lack the necessary ATP levels.
That’s what I plan to do. So what would you do if you were in my
shoes? Do nothing?

A National General Nasal Spray Approach

As with vaccines and drugs the establishment of a national research
and development effort is urgently needed. The very good news is that,
unlike vaccines and drugs, the costs of discovery and development of a
nasal spray is far, far, far less as well as the time required to conduct
the clinical trials and achieve adequate national distribution.
In addition, there is a cornucopia of generally available potential nasal
spray candidates such as hydrogen peroxide, hypochlorous acid, nitric
oxide and even saline, if, however, delivered properly. Another NIH
division is evaluating a promising candidate with a different mechanism
of action. The frequent administration necessary during prolonged
pandemics, however, would require long-term safety studies. And, for
the record, I believe a high percentage will inevitably fail this
There are, unfortunately, real world economic and social considerations
that can stand in the way of nasal spray pursuits. Many of the active ingredient candidates may not be supported by a strong enough
proprietary position such as a patent to justify financial investments by
pharmaceutical companies or other potential sources. Also,
understandable concern already has been raised that effective
alternative therapies such as the nasal spray would discourage large
segments of our population from taking effective vaccines and drugs.
On the other hand, despite such barriers the compelling urgent national
need combined with the large market potential will inevitably lead to
innovative organizations or individuals who will take the chance and
invest in highly promising nasal spray research.

The Need to Establish a Nasal Spray National Stockpile and When to Begin

Because of the magnitude of the threat to our national security and
well- being, when it’s determined that the initial clinical study data are
unequivocally positive, even before the study is completed, a
commitment to expeditiously establish a national stockpile of the nasal
spray should be placed into motion with the capability of rapid
expansion depending on further clinical data on its efficacy and safety.
When produced in sufficient quantities, it should be distributed to
individual States to maximize efficient national distribution.

A Call to Potential Leaders

I’ve been asked what specific organizations or even wealthy individuals
such as Jeff Bezos, Bill Gates and Elon Musk would invest in the anti-
Covid nasal spray effort in order to avoid the possibility of the crippling
and weakening of America, and, let’s not forget, leaving us particularly
vulnerable to unfriendly powers. Or, even a capable charismatic political leader. Or, how about a creative international source? This
remains to be seen. What is critical at this point in time, however, is
that the message of the Nose opportunity and the lessons learned of
the anti-allergic steroid nasal sprays be rapidly first understood and
And, hopefully, this post will help lead to such an awareness followed
by some type of highly productive national nasal spray approach.